Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for China
FDA Apostille for China
Since 7 November 2023, mainland China has accepted apostilles, replacing the slow two-step process of State Department authentication followed by Chinese embassy legalization. An FDA export certificate for an NMPA or SAMR file now needs a single U.S. Department of State apostille. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 7 November 2023
- Apostilledocument route
- Chinese (Mandarin)official language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why China Asks for an Apostilled FDA Certificate
China's accession to the Hague Convention was one of the biggest simplifications in years for U.S. health-product exporters. Before November 2023, every FDA certificate bound for a Chinese registration had to be authenticated in Washington and then legalized by a Chinese embassy or consulate, often adding weeks. Now the State Department apostille is the only legalization step. For imported cosmetics filed with the National Medical Products Administration (NMPA), for example, an apostille alone now replaces embassy certification of notarized documents.
The registration rules themselves remain demanding. NMPA registers drugs, medical devices and cosmetics, and overseas applicants generally need proof that the product is approved for sale in their home country. The State Administration for Market Regulation (SAMR) registers infant formula, foods for special medical purposes and health foods. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We arrange that and ship the result to you or your Chinese agent.
Which FDA Certificate Does Your Chinese Importer Need?
Match your product to the Chinese authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Chinese authority | FDA certificate |
|---|---|---|
| Medicines | National Medical Products Administration (NMPA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | NMPA, with proof of approval in the registrant's home country | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, infant formula & FSMPs | SAMR (product registration) and GACC (overseas facility registration) | Certificate to a Foreign Government (CFG), Health Certificate |
| Health foods (supplements) | SAMR, health food registration or filing | Certificate of Free Sale (CFS) |
| Cosmetics | NMPA, cosmetic registration or notification | Certificate for Cosmetics |
NMPA, SAMR and the customs authority GACC each have their own systems and document lists. The apostille rules apply to mainland China. Hong Kong and Macao have long accepted apostilles separately. Your Chinese agent will confirm the certificate each authority needs.
How the FDA Apostille for China Works
The Hague Apostille Convention has been in force for China since 7 November 2023, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose China as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Shanghai or anywhere else.
Exporting to China: What to Prepare
No more embassy legalization
Since 7 November 2023, U.S. public documents such as FDA certificates no longer need Chinese embassy or consulate legalization. Budgets and timelines built around the old two-step process can be cut down. The apostille confirms the seal and signature, while the content is still reviewed by the Chinese authority.
Overseas food facilities must register
Under GACC Decree 248, in force since 1 January 2022, overseas manufacturers of food exported to China must register with China's customs authority. Higher-risk categories are recommended by the U.S. competent authority, and others self-register. Facility registration runs alongside product registration and your apostilled certificates.
Chinese translations
Chinese authorities work in Chinese, so foreign documents in a registration file are submitted with Chinese translations. Apostille the FDA certificate first, then have it translated, so the translation covers the apostille as well.
A domestic agent or responsible person
Overseas manufacturers register through a legal entity in China, such as a domestic agent for devices and drugs or a domestic responsible person for cosmetics. Make sure the manufacturer and product names on your FDA certificate match exactly what your agent files.
FDA Apostille Cost for China
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88 / doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for China: FAQs
Does China accept apostilles?
Yes. The Hague Apostille Convention has applied to mainland China since 7 November 2023. A U.S. Department of State apostille replaces the old Chinese embassy or consulate legalization.
Do I still need Chinese embassy legalization for FDA certificates?
No. Since November 2023, U.S. federal documents such as FDA certificates only need an apostille for use in mainland China. Documents from countries outside the Convention still go through legalization.
Which Chinese authorities use FDA certificates?
The National Medical Products Administration (NMPA) for drugs, medical devices and cosmetics, and the State Administration for Market Regulation (SAMR) for infant formula, foods for special medical purposes and health foods.
Do U.S. food manufacturers need to register in China?
Yes. Under GACC Decree 248, in force since January 2022, overseas manufacturers of food exported to China must register with China's customs authority, either via the U.S. competent authority or by self-registration, depending on the product category.
Is the process different for Hong Kong or Macao?
Hong Kong and Macao have their own rules and accepted apostilles long before the mainland did. See their dedicated pages.
How long does an FDA apostille for China take and what does it cost?
Standard processing takes 9 business days and costs $88 per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for China
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Apostilled for China
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88 per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Total:
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